Upcoming study of another biological molecular targeting strategy, novel compared to many. United States centers for this study should become available as this is an international study.
SHANGHAI and HONG KONG, January 4, 2021 / PRNewswire / – Antengene Corporation Limited (“Antengene”, SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to the discovery, development and commercialization of world-class and / or world-class therapeutics in hematology and oncology, announced that that it has filed an Investigational New Drug (IND) application with the National Medical Products Administration (NMPA) for ATG-010 (Selinexor) for the treatment of endometrial cancer. This is a Phase 3, multicentre, double-blind, randomized, global study (SIENDO) aimed at evaluating the effectiveness of ATG-010 versus placebo as maintenance therapy in patients with advanced or recurrent endometrial cancer after combination chemotherapy 80 investigative agencies around the world, underneath North America, Europe and Asia.
ATG-010 is a premier and only oral selective inhibitor of nuclear export developed by Antengene and Karyopharm Therapeutics Inc. (NASDAQ: KPTI). It has been approved by the US Food and Drug Administration (FDA) for use in both multiple myeloma and diffuse large B-cell lymphoma, which are two main indications for hematological malignancies. In addition, the Phase 3 SIENDO study of ATG-010 in patients with endometrial cancer passed the planned preliminary futility analysis and the Data and Safety Monitoring Board (DSMB) recommended that the study continue as planned without changes.